The return of Vinay Prasad
Vinay Prasad is to return to his role as director of the FDA’s Center for Biologics Evaluation and Research – only two weeks after leaving the role.
He previously spent three months in the position before resigning – following criticism of the agency’s handling of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy. Media reports have alleged that he was pushed out of the role.
FDA updates safety labelling for Bluebird Bio therapy
The FDA has updated the safety labeling for bluebird bio’s Skysona (elivaldogene autotemcel) after new data showed a higher-than-previously-reported risk of blood cancers.
When Skysona was granted accelerated approval in 2022 for the treatment of early, active cerebral adrenoleukodystrophy in patients without a suitable allogeneic hematopoietic stem cell donor, three out of 67 patients in clinical trials had developed myelodysplastic syndrome. As of July 2025, the number had risen to ten, representing about 15 percent of treated patients. Diagnoses occurred between 14 months and 10 years post-treatment. Most affected patients underwent allogeneic stem cell transplantation, and one death linked to malignancy treatment has been reported.
The FDA has revised the product labeling to restrict use to patients without an available HLA-matched donor. Lifelong monitoring for hematologic malignancy also remains a requirement, with regular blood counts and follow-up assessments recommended.
US scraps funding for mRNA vaccines
The US Department of Health and Human Services is cancelling 22 mRNA vaccine development projects against bird flu and other viruses. Affected companies include Pfizer, AstraZeneca, Moderna, Sanofi and Seqirus.
The projects – were $500 million – were carried out under the Biomedical Advanced Research and Development Authority (BARDA). A statement from HHS Secretary Robert F Kennedy Jr claims: “BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”
Some final-stage contracts, including those with Arcturus and Amplitude, are being allowed to run their course.
Sartorius Stedim Biotech and Nanotein Technologies partner
Sartorius Stedim Biotech has formed a new partnership with Nanotein Technologies, a California-based developer of advanced immune cell activation reagents. As part of the deal, Sartorius will take a minority stake in Nanotein – up to 3 million US dollars – and will work with the company to further develop and commercialize its NanoSpark platform.
Nanotein’s reagents, the NanoSpark STEM-T Soluble T Cell Activator and the NanoSpark GROW-NK Soluble Activator, aim to tackle persistent challenges in cell therapy manufacturing by boosting the quality and yield of T cells and natural killer cells, while reducing reliance on feeder cells.
Both companies plan to build on the NanoSpark technology to create new tools for the cell and gene therapy sector, with Sartorius Stedim Biotech positioning the partnership as a way to streamline workflows and help therapy developers move more quickly from early process development to clinical application.
“Nanotein’s soluble activators are designed to improve cell therapy expansion by enhancing the quality and quantity of T cells and providing a feeder-free soluble activator for NK cell activation and expansion, addressing critical challenges in the manufacturing process”, says Curtis Hodge, Co-Founder and CEO of Nanotein Technologies.
Axplora expands in India
Axplora is investing €6.5 million to expand its API manufacturing facility in Vizag, India. The expansion is intended to increase production capacity, enhance supply chain resilience, and consolidate manufacturing operations on a single site.
The company also reports successful completion of routine FDA inspections at Vizag and another site in India, Chennai. The Chennai site was noted for the quality of its cGMP implementation, documentation processes, and facility maintenance standards.
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